Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study of tavilermide (mim-d3) ophthalmic solution for the treatment of dry eye disease

Conditions: Keratoconjunctivitis Sicca

Summary: the purpose of this study is to assess the safety and efficacy of tavilermide ophthalmic solution compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye disease.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age. * provided written informed consent. * have a reported history of dry eye have a history of use or desire to use eye drops for dry eye exclusion criteria: * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at visit 1. * be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months. * have any planned ocular and/or lid surgeries over the study period. * have corrected visual acuity greater than or equal to +0.7 as assessed by early treatment of diabetic retinopathy study (etdrs) scale in both eyes at visit . * have an uncontrolled systemic disease. * be a woman who is pregnant, nursing or planning a pregnancy. * be a woman of childbearing potential who is not using an acceptable means of birth control * have a known allergy and/or sensitivity to the test article or its components. * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of visit 1 be unable or unwilling to follow instructions, including participation in all study assessments and visits

Keywords: dry eye
cardinal adjustable annuloplasty ring system for treatment of mitral regurgitation

Conditions: Mitral Valve Insufficiency

Summary: annuloplasty device for repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. unlike conventional annuloplasty ring, the cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.


Eligibility criteria:
inclusion criteria: * patient is a candidate for mitral valve repair. * patient able and willing to return to the implant center for follow-up visits. * able and willing to give informed consent and follow protocol procedures. exclusion criteria: * severe organic lesions with retraction of chordate tendineae, severly fibrotic and immobile leaflets, severely deformed subvalvular apparatus. * evolving endocarditis or active endocarditis in the last 3 months. * heavily calcified annulus or leaflets. * congenital malformation with limited valvular tissue * patient requires mitral valve replacement. * previously implanted prosthetic mitral valve or annuloplasty ring/band. * patient requires aortic or pulmonic valve replacement or repair. * patient is pregnant (urine hcg test result positive) or lactating. * patient has a major cardiac or non-cardiac disease, which in the investigator's experience produces an unacceptable surgical risk. * life expectancy of less than twelve months. * patient is participating in concomitant research studies of investigational products

Keywords: heart diseases heart valve diseases cardiovascular diseases
efficacy and safety of romosozumab treatment in postmenopausal women with osteoporosis

Conditions: Postmenopausal Osteoporosis

Summary: the purpose of this study is to determine if treatment with romosozumab is effective in preventing fractures in women with postmenopausal osteoporosis


Eligibility criteria:
inclusion criteria: - postmenopausal women with osteoporosis, defined as low bone mineral density (bmd t-score at the total hip or femoral neck of ≤ -2.50) exclusion criteria: * bmd t-score of ≤ -3.50 at the total hip or femoral neck * history of hip fracture * any severe or more than 2 moderate vertebral fractures, as assessed by the central imaging based on lateral spine x-rays * use of agents affecting bone metabolism * history of metabolic or bone disease (except osteoporosis) * vitamin d insufficiency (vitamin d repletion and rescreening is permitted) * current hyper- or hypocalcemia * current, uncontrolled hyper- or hypothyroidism * current, uncontrolled hyper- or hypoparathyroidism

Keywords: osteoporosis, osteoporosis-postmenopausal, bone diseases-metabolic, bone diseases, musculoskeletal diseases
cochlear implantation after gamma knife radiosurgery with eabr and correlation to postoperative hearing results - a pilot study

Conditions: Vestibular Schwannoma; Hearing Loss

Summary: patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. patients will undergo preoperative and intraoperative eabr measurement. correlations to postoperative hearing results will be drawn.

patients treated with radio surgery for vestibular schwannoma often suffer from hearing loss. especially when the contralateral side has progressive hearing loss assessment if cochlear implantation is feasible, should be carried out. patients undergo extensive audiometric testing. additionally, patients will undergo preoperative eabr. intraoperatively eabr is carried out and cochlear implantation is performed. the eabr results will be correlated with postoperative hearing. eabr measurements are not part of the study. the results of ebar will be categorized in three groups (good response, weak response and no response). the eabr results will then be correlated to speech understanding with cochlear implants measured with freiburger monosyllables test.

Eligibility criteria:
inclusion criteria: * patients who have undergone radio surgery for vestibular schwannoma * patients wanting cochlear implantation for hearing rehabilitation exclusion criteria: * patients not wanting to participate in the study
diagnosis of metastatic tumors on 68ga-fapi-rgd pet-ct and radioligand therapy with 177lu-fapi-rgd

Conditions: FAP- Expressing Positive Tumors; RGD- Expressing Positive Tumors

Summary: fap and rgd are overexpressed in many tumor tissues. this study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177lu-fapi-rgd--a new dual-targeted 177lu therapeutic drug for the first time in the world.

fibroblast activation protein (fap) and rgd are serine peptidase on the surface of tumor associated fibroblasts. it has special biological characteristics and stable genome. they are usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction,receptor imaging with a single target also has some limitations in clinical application. for example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. the dual-target molecular imaging based on fap expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors and used to 177lu prrt. we'll try to assess the safety and therapeutic response to 177lu-fapi-rgd in patients with metastatic tumors in human.

Eligibility criteria:
inclusion criteria: * confirmed treated or untreated metastatic tumors patients; * 68ga-fapi pet/ct and 18f-fdg pet/ct within two weeks; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance
alateral flow assay to detect qsox1 peptide in patients with or at risk for pancreatic cancer

Conditions: Pancreas Cancer; Pancreas Cyst

Summary: researchers have developed a new test to measure a protein qsox1 that is found to be elevated in subjects with pancreas cancer. researchers are looking to use this test to compare subjects with pancreas cancer and subjects without pancreas cancer to see if this test could be used to diagnosis pancreas cancer.


Eligibility criteria:
inclusion criteria: * adult patients with biopsy-proven adenocarcinoma prior to receiving any therapy such as surgery, radiation or chemotherapy. * patients without pancreas cancer. * adult patients with benign pancreas disorders such as pancreatitis with imaging within 12 months (ct, mri, eus) documenting no cancer. * healthy adults with blood specimens in an existing biobank. * patients with pancreatic cystic lesions. * adult patients undergoing clinically indicated eus-guided fna biopsy of pancreatic cystic lesions. exclusion criteria: * prior treatment for pancreas cancer. * unable or unwilling to give consent.
study of prevalence of proteinuria, urinary tract infection or hematuria in athletes

Conditions: Proteinuria

Summary: to understand the urine analysis of athletes

there maybe some genitourinary problem related to athletes, such as proteinuria, hematuria, scrotal pain, std, etc. to explore these problems and give adequate management for them not only improved athletes' health, but also it can do their best in their exercise performance.

Eligibility criteria:
inclusion criteria: * proteinuria, hematuria, pyuria exclusion criteria: * bacteriuria

Keywords: hematuria urinary tract infection
electroretinogram and retinal vascular changes after cataract surgery

Conditions: Primary Open Angle Glaucoma

Summary: to compare electrophysiological and optical coherence tomography angiography of optic disc and macula changes after uneventful phacoemulsification between normal and cataractus patients with primary open angle glaucoma.

* study design: a prospective, non randomized, interventional, comparative study, control based study. * location: ophthalmology department, sohag university hospital. in this prospective study, aiming to investigate optical coherence tomography angiography and electrophysiological changes after cataract surgery in normal and patients with poag with cataract 1 day before operation, 1 week and 3 months postoperatively. * methodology the study will include 50 patients with primary open angle glaucoma associated with cataract and 50 patients have cataract without glaucoma. preoperative and postoperative evaluation: all patients will be subjected to the following: * history taking including age, gender, family history, systemic diseases, previous medications or ophthalmic surgery. * detailed ophthalmological examination including: uncorrected visual acuity (ucva), best corrected visual acuity (bcva) by snellen's fraction and converted into logarithm of the minimal angle of resolution logmar, refraction, keratometry, slit lamp biomicroscopy for anterior segment, iop measurement by applanation tonometer, and posterior segment (fundus) examination. * examination of the angle of anterior chamber by goniolens. * octa disc and macula * pattern erg and multifocal erg surgical techniques: patients will be subdivided into two groups: group (a): normal patients will undergo standard phacoemulsification surgery. group (b): patients with poag will undergo standard phacoemulsification surgery. \* phaco technology by using (whitestar signature pro, abbott, usa) * oct angiography will be done by (optovue, inc., fremont, california, usa). * electrophysiology will be done by (roland consult retimap, germany)

Eligibility criteria:
inclusion criteria: * patients aged: 45-65 years old with cataract density doesn't interfere with pre-operative imaging (n1-n2). * patients with primary open angle diagnosed for at least 2 years with glaucoma treatment associated with cataract (n1-n2). exclusion criteria: s▪ patient with pacg. * previous intraocular surgery. * associated ocular or intra ocular inflammation * previous history of eye trauma. * associated intraocular pathology

Keywords: octa: optical coherence tomography angiography erg: electroretinogram poag: primary open angle glaucoma v/a: visual acuity iop: intra ocular pressure
impact of vitamin d therapies on chronic kidney disease

Conditions: Chronic Kidney Disease (CKD); End-stage Renal Disease (ESRD)

Summary: this investigation will consist of a prospective study utilizing two separate populations of patients with 25(oh)d deficiency, one population with chronic kidney disease (ckd) and one with normal renal function.

vitamin d helps form and strengthens bones by allowing the body to absorb calcium. vitamin d helps the immune system fight infection as well as helps keep muscles strong. without enough vitamin d, bones can become weak, thin and brittle. vitamin d is useful in people with all different types of health issues. ckd is the slow loss of kidney function over time. the main function of the kidneys is to remove wastes and excess water from the body. this loss of function usually takes months or years to occur patients with ckd often have low levels of vitamin d in their blood. this study will have two groups of patients with ckd and one group of patients that have normal kidney function, but all groups will have low levels of vitamin d. the two groups with ckd (group 1 and group 2) will receive either cholecalciferol or calcitriol. the purpose of having a control group (group 3) without ckd will be to evaluate if any changes that are witnessed in response to vitamin d therapy are specific to patients with kidney disease or apply to all patients with vitamin d deficiency who receive vitamin d supplements. there are two different drugs in this study. one is called calcitriol and is approved by the food and drug administration (fda) as a vitamin d supplement. the other drug is called cholecalciferol and it is approved by the fda. unlike calcitriol, cholecalciferol is a nutritional form of vitamin d that can often be found in various types of foods and its chemical structure must be changed by the body to become the active form of vitamin d. it is believed that cholecalciferol may have different effects in the body compared to calcitriol. it is possible that ckd patients would benefit from receiving both of these drugs, but this is currently unclear. while on this study you will receive either one of these study drugs, depending on which group you are assigned to.

Eligibility criteria:
inclusion criteria: * chronic kidney disease w/gfr\<35ml/min * nutritional vitamin d deficiency, defined as 25(oh)d \< 25ng/ml * secondary hyperparathyroidism, pth\>75pg/ml exclusion criteria: * active infection * recent hospitalization for acute illness (within last month) * refusal to study participation * history of chronic inflammatory disease process (i.e. inflammatory bowel, rheumatoid arthritis, sle, etc.) * allergy to cholecalciferol or calcitriol * history of parathyroidectomy * functional renal transplant within 5 years * current treatment with immunosuppressant medications * noncompliance with prescribed medications
the effects of creative dance based exercise training on respiratory, balance and cognitive functions, respiratory and peripheral muscle strength and functional capacity in patients with chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: copd is a common, preventable and treatable disease associated with an increased chronic inflammatory response of the airways and lungs to harmful gases and particles and characterized by progressive airflow restriction, which is usually progressive. exercise intolerance is one of the most important outcomes of copd. dyspnea and leg fatigue are the main symptoms that limit exercise and patients restrict their activity to avoid these disturbing conditions. exercise training is the most appropriate method for improving exercise tolerance and muscle function. it is considered and recommended by ers and ats as an essential component of pr. endurance training is considered to be one of the most important components of the pr program. walking, running, cycling, stair climbing, dancing are examples of endurance exercises. dance-based exercise training; it is an entertaining method that increases physical, functional, cognitive, emotional and social integration. this alternative method has frequently been tried in the literature in the treatment of parkinson's, cancer and psychiatric diseases and its effects on functional capacity, balance, and quality of life have been demonstrated. the importance of our research; this is the first study to apply dance based exercise training in chronic respiratory diseases. the aim of this study was to investigate the effect of creative dance based exercise training on respiratory, balance and cognitive functions, respiratory and peripheral muscle strength and functional capacity in copd patients.


Eligibility criteria:
inclusion criteria: * having fev1 / fvc \<70% from pulmonary function test * being older than 18 years * to be able to read and understand turkish exclusion criteria: * no exacerbation in 8 weeks. * attending current or regular exercise training in the last 1 year * having diagnosed vision, hearing, vestibular or neurological problems that may affect balance * having orthopedic, musculoskeletal or cardiovascular comorbid conditions that may affect ambulation * being on long-term oxygen therapy

Keywords: copd creative dance exercise training 6 minute walk test pulmonary function test postural stability cognitive functions muscle strength
qiastat-dx® bcid plus amr panels clinical performance study

Conditions: Blood Disease

Summary: study for performance evaluation of the qiastat-dx® bcid plus amr gpf-panel and the qiastat dx® bcid plus amr gn-panel in comparison with other chosen comparator methods

this multicenter study aims to evaluate the performance of qiastat-dx® bcid plus amr gpf-panel and the qiastat dx® bcid plus amr gn-panel with another validated comparator method.

Eligibility criteria:
inclusion criteria: * positive (as identified through gram stain) blood culture media specimens cultured within bottle types listed in ifu. * residual and de-identified specimens. * specimen from subject who has not previously been enrolled. * fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity. * frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity. * minimum 1.5 ml volume available * in stage 2 - pure colony isolates of bacilli, actinobacteria, fungi (except fusarium), enterobacterales, pseudomondales, nesseriales, pasteurellales, bacterioidales, or xanthomonadales. exclusion criteria: * positive blood culture specimens inoculated with a sample type other than blood (i.e. paracentesis, or other body fluids) * specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected). * frozen specimens which are unable to be cultured after thawing. * specimen from subject previously enrolled
an artificial intelligence-assisted digital health lifestyle intervention for adults with hypertension

Conditions: Hypertension

Summary: this study evaluates the impact of a fully digital, autonomous, and artificial intelligence (ai)-driven lifestyle coaching program on managing blood pressure (bp) among adults diagnosed with hypertension. participants received a bp monitor and a wearable activity tracker to facilitate data collection. this data, along with responses from a questionnaire mobile app, were analyzed by an automated analytics engine employing statistical and machine learning techniques. the program delivered tailored lifestyle coaching directly to participants through a mobile app, aiming for precise and effective bp management.


Eligibility criteria:
inclusion criteria: * age ≥18 years * stage 2 hypertension based on their most recent clinical measurement (sbp ≥ 140 mmhg or dbp ≥ 90 mmhg per the 2017 american college of cardiology/american heart association guidelines) * speaking and reading english * having an apple iphone 6s or later, or an android phone running android 8.0 or later exclusion criteria: * self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes) * current participation in a lifestyle modification program or research study * self-report of being currently pregnant
trastuzumab (herceptin), paclitaxel, carboplatin and gemcitabine in advanced urothelial cancer

Conditions: Urologic Neoplasms

Summary: purpose: the purpose of this study is to evaluate the efficacy and safety of treatment with trastuzumab (herceptin) along with the three other chemotherapy drugs, paclitaxel, carboplatin and gemcitabine, in patients who have advanced urothelial cancer. this clinical trial will also collect information (alternative therapy, response rates, overall survival) from enrolled patients with her2 negative tumors who are ineligible to receive study treatment.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of urothelial carcinoma (tcc or squamous) that is either metastatic or locally recurrent and not curable by surgery or radiation therapy. * all patients must have tissue from either the primary or metastatic site tested for her2 status determination. patients with her-2 negative tumors are not eligible for treatment on this protocol. * all patients must have a blood sample drawn for her2 serologic testing. * if the available tissue is from the primary tumor and is her2 negative and if the serum is negative, to qualify for the study a biopsy of a metastatic site should be done and the patient will be eligible only if this demonstrates her2 over-expression. * patients may not have received prior systemic chemotherapy for metastatic disease. patients may have received adjuvant chemotherapy if completed at least 6 months prior to beginning this protocol treatment. * patients may not have cardiac disease and must have adequate cardiac function (ejection fraction \> 50% or higher than the lower limit of institutional normal) as determined by a muga scan or 2-d echocardiogram within 4 weeks from registration, and no evidence of symptomatic coronary artery disease (baseline ekg must show no active ischemia). patients must not have history of congestive heart failure. * if patients have received prior radiation therapy, disease must be present outside of radiated fields and at least 4 weeks must have elapsed since discontinuation of that therapy. exclusion criteria: * pregnant or lactating women may not participate. * hiv - positive patients may not participate. this is to avoid additional complications that immune suppression and hiv infection may cause due to the intense nature of the chemotherapy in this trial.

Keywords: urothelial cancer herceptin advanced urothelial cancer
fecal microbiota transplantation for relapsing clostridium difficile infection

Conditions: Clostridium Difficile Infection

Summary: randomized open label clinical trial to compare the clinical and microbiological efficacy of fecal microbiota transplantation, fidaxomicin, and vancomycin for relapsing clostridium difficile infection


Eligibility criteria:
inclusion criteria: 1. relapse of clostridium difficile infection with previous trial of vancomycin or fidaxomicin exclusion criteria: 1. pregnancy or breastfeeding 2. does not speak or understand the danish language 3. current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin 4. fulminant colitis which contraindicates medical treatment 5. physician's evaluation that the patient cannot tolerate project inclusion